Alcami

Expert sterile fill finish manufacturing services from preclinical product development to commercial launch, including liquid and lyophilized injectable drug products in vials and syringes.

An alternative microbiological test method to traditional USP <71>, Ph. Eur. 2.6.1, and JP 4.06 sterility tests utilizing the Milliflex Rapid System for faster results through ATP bioluminescence.

Comprehensive drug product manufacturing services supporting pharmaceuticals and biologics from development to delivery.

Comprehensive stand-alone stability testing services and in-process studies for pharmaceutical drug products and active pharmaceutical ingredients, supporting drug development from early stages to commercialization.

Specialized analytical and testing services for Advanced Therapy Medicinal Products.

Secure cGMP freezer storage services at -20°C, -40°C, and more, offering continuous environmental monitoring and validated inventory management for APIs, biofluids, drug products, and research samples.

Custom packaging, labeling, and kitting for clinical trial materials including randomization, blinding studies, serialization, and destruction services.

Biopharmaceutical analytical development, stability programs, microbiology, and routine testing services.

Comprehensive compendial testing services adhering to standards such as USP, Ph.Eur., BP, JP, ChP, FCC, and ACS, providing accurate and timely results with standard turnaround times.

Comprehensive analytical service and flexible resource pool providing collaborative solutions for pharmaceutical and biotech drug development, spanning method development, validation, and full quality control.

Specialized pharmaceutical storage facilities designed to meet rigorous cGMP standards, located in New England, Garner, NC, and Reno, NV.

Ultra-low temperature storage solutions for specialized biopharmaceutical products.

Flow cytometry analytical services for cell and gene therapy and biologics characterization.

Validated cold chain transportation services for pharmaceutical products.

Fully integrated laboratory testing services including extractables and leachables testing, analytical testing, and microbiology.

Analytical testing services including RP, IP, IEX, SEC, MALS, CE, SDS-page, and UV/Vis for potency, purity, identification, and excipients.

Specialized laboratory-based in-vitro manipulation and extraction testing services designed to evaluate prescription drug formulations for abuse resistance in compliance with FDA guidelines.

Alcami provides comprehensive design and execution of food and drug interaction studies supporting various oral solid dosage forms including tablets, capsules, and suspensions.

Comprehensive analytical testing services to assess extractable and leachable compounds ensuring drug product quality remains unaffected by packaging, in-use components, or manufacturing processes.

In-house and on-site CQV services providing documented evidence that equipment and instrumentation is installed correctly, operating accurately, and performing reliably.

Customized kitting solutions for clinical trials and pharmaceutical supply chains.

Multiple ICP-MS capabilities such as catalyst control, assay determination, organometallic compounds, and cleaning verification methods.

Comprehensive analytical testing and risk assessment services for nitrosamines, including paper-based risk assessments, R&D screening, and method validation and testing.

Micro-Flow Imaging services for particle analysis in biologic formulations.

Primary Standards lab services offering Class 1 Mass Calibrations and calibrations across temperature, pressure, relative humidity, electrical, and other parameters with NIST traceability and ISO/IEC 17025:2017 accreditation.

Advanced Mycoplasma testing using qPCR technology offering rapid and sensitive detection of contamination in biological samples.

Expert on-site support in Calibration, Commissioning, Qualification, Validation, and Environmental Monitoring ranging from full-time staff augmentation to specialized project-based support.

Pharmaceutical labeling services ensuring regulatory compliance and tracking.

Cell-based bioassay testing services for biologics and large molecule programs.

Orthogonal analytical methods for assay verification and related substance identification.

Enzyme-Linked Immunosorbent Assay testing services for large molecules.

Professional aliquoting and sampling services for pharmaceutical materials management.

Enzyme activity testing services to support biologics development and quality control.

Secure management and storage of pharmaceutical reference standards.

Services designed to enhance sterility assurance programs, providing tailored sampling, testing, and consultation supported by rigorous training and ALCOA principles.

Accurate and precise calibration services for pressure units ensuring the stability, controllability, and repeatability of sensitive production processes and end products, supporting 0 PSI to 1000 PSI.

Paperless system that streamlines data collection, analysis, and reporting for efficient and compliant environmental monitoring.

Active air samplers used for viable active air testing.

Comprehensive cycle counting and annual inventory management services.

Units used for total particle count testing in cleanroom environments.

Compressed gas units used for comprehensive analysis of compressed gas systems.